Corneal damage causes significant vision loss in the general world population, second only to cataracts, each year. Corneal replacement is a developing technology that is rapidly becoming a necessity for many patients. Many of the reasons for corneal replacement therapies include scarring from disease (e.g. herpes infection), complications from LASIK surgery, hereditary problems (e.g., Fuch's disease), and complications from other surgeries (e.g., cataracts).
Current strategies employed for corneal grafting make use of allogenic or synthetic materials. These strategies are only partially effective, however, and may stimulate host immune responses that result in tissue rejection. In addition, there is the potential for transfer of diseases from unhealthy donor organs. These issues are compounded by the growing use of corrective eye surgery which renders corneas unsuitable for grafting which will further impact the availability of acceptable allogenic supplies.
The use of grooved substrates has been demonstrated in the literature to induce cell and extracellular matrix (ECM) alignment upon various substrates (Ingber, 2003; Dalby et al., 2003; Walboomers et al., 1999; den Braber et al., 1998; Dunn and Brown, 1986). These methods have been employed in part as an effort to control tissue development. Most of the material substrates (i.e. titanium, silicone, PDMS and PEO) used in these studies are not readily degraded by the body or are not suitable for use in vivo. Hence, while possible applications in tissue development have been explored with these substrates, the cultured cells grown upon the substrates cannot be implanted, significantly limiting their practical use. Furthermore, these materials may cause stress induced cell responses that may disrupt normal cell function and tissue development over time.
Thus, what is needed in the art is a tissue-engineered cornea replacement system, made with a material that is optically clear, non-immunogenic, and biocompatible material. This invention answers that need.